UK biotech firm ReNeuron has received the expected final regulatory approval it needs to start trials of stem cell therapy for stroke victims, the Guildford-based company said today.

As noted by Nature News earlier this year, this trial will be the first time that brain-derived stem cells – originally isolated from a human fetus – have been used to treat stroke patients. The trial will involve 12 patients and will take place at Glasgow’s Southern General Hospital in Scotland. (For more, see: Green light for UK stem-cell trial, Nature News 19 January 2009.)

“This final approval represents the culmination of many months of work in taking our ReN001 therapy through the regulatory pathway in the UK, a process untested by other stem cell therapy approaches of this type,” says. Michael Hunt, ReNeuron’s CEO (press release).

“We are therefore pleased to have in many ways pioneered this pathway for subsequent cell therapy applications.”

As this is a phase one trial, its primary purpose is to assess the safety of the treatment. There will also be some measures of ReN001’s clinical efficacy.

ReNeuron had previously tried to take forward a phase one trial on this product in the US. However the Food and Drug Administration was cautious and the trial has ended up in the UK.

As the Financial Times notes:

The company received a cool response when it sounded out UK and European regulators in 2005, so it went to the US instead. But the Food and Drug Administration kept delaying approval. In 2008 ReNeuron went back to the UK Medicines and Healthcare Regulatory Agency, which was more positive the second time around.